Health Care Economic Information Communications to Payors for Medical Devices
This guidance addresses how medical device manufacturers can communicate health care economic information (HCEI) to payors, formulary committees, and similar entities. It covers both approved/cleared devices and unapproved devices/uses. The guidance aims to help manufacturers provide truthful, non-misleading information while enabling payors to make informed coverage and reimbursement decisions.
What You Need to Know? 👇
What is Health Care Economic Information (HCEI) and how can medical device manufacturers communicate it to payors?
HCEI analyzes economic consequences of medical product use, including costs and resource utilization related to clinical outcomes. Device manufacturers can present HCEI through evidence dossiers, peer-reviewed publications, budget-impact models, or slide presentations to qualified payors with health economic expertise.
Which audiences can receive HCEI communications about medical devices under FDA guidance?
Appropriate audiences include payors, formulary committees, pharmacy benefit managers, technology assessment committees, and multidisciplinary entities with health care economic analysis expertise. These entities must have deliberative processes and knowledge to interpret HCEI for population-based coverage and reimbursement decisions.
What evidentiary standards must support HCEI for medical devices?
HCEI must be based on competent and reliable scientific evidence using generally accepted scientific standards. FDA considers guidelines from authoritative bodies like ISPOR, ISPE, PCORI, and AHRQ. The evidence should yield accurate, reliable results appropriate for the information being conveyed.
What key information should be included when presenting device HCEI to payors?
Essential elements include study design and methodology, patient population details, perspective/viewpoint, outcome measures, cost estimates, assumptions, generalizability factors, limitations, sensitivity analyses, and material differences from FDA-required labeling. All information should be presented clearly and prominently.
Can manufacturers communicate information about unapproved medical devices to payors?
Yes, manufacturers may provide factual, unbiased information about unapproved devices including product descriptions, indication sought, development timeline, pricing, and factual study results. Communications must clearly state the product is not approved and safety/effectiveness hasn’t been established.
What promotional material submission requirements apply to device HCEI communications?
Unlike drug manufacturers, device companies are not subject to postmarketing reporting requirements for promotional materials under 21 CFR 314.81(b)(3)(i). However, HCEI communications are still considered promotional labeling and must not be false or misleading under general FDA requirements.
What You Need to Do 👇
Recommended Actions
- Establish internal review process to ensure HCEI is truthful, non-misleading and based on competent and reliable scientific evidence
- Develop templates for HCEI communications that include all required elements:
- Study design and methodology
- Limitations and generalizability
- Risk information
- Required statements and disclosures
- Create process to track and provide follow-up information for communications about unapproved products/uses
- Train relevant staff on requirements for HCEI communications and appropriate audience
- Maintain documentation of scientific evidence supporting HCEI claims
- Implement process to review and update HCEI communications when new information becomes available
- Establish procedure to ensure appropriate disclosures of financial/affiliation biases
- Create system to track and respond to payor requests for additional information
- Develop process to ensure consistency between HCEI communications and FDA-required labeling
- Maintain records of all HCEI communications for reference
Key Considerations
Labelling
- Must include FDA-required labeling for approved/cleared devices
- Must include clear statement if product/use is not approved/cleared
- Must include prominent statement disclosing approved/cleared indications when discussing unapproved uses
Safety
- Must disclose important risk information associated with approved use
- Must disclose additional risk information related to clinical assumptions that vary from FDA-required labeling
Other considerations
- HCEI must be based on competent and reliable scientific evidence
- Must include study design and methodology information
- Must disclose limitations and generalizability of analyses
- Must include sensitivity analyses
- Must disclose financial/affiliation biases
- For unapproved products/uses:
- Must provide information about development stage
- Must present study results factually without effectiveness claims
- Must provide follow-up if information becomes materially outdated
Relevant Guidances 🔗
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms 📂
- ISPOR: International Society for Pharmacoeconomic and Outcomes Research guidelines
- ISPE: International Society for Pharmacoepidemiology guidelines
- PCORI: Patient-Centered Outcomes Research Institute guidelines
- AHRQ: Agency for Healthcare Research and Quality guidelines